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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02857894
Other study ID # MMT_2015_4
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 5, 2015
Est. completion date October 23, 2018

Study information

Verified date October 2018
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Polypoidal choriodal vasculopathy (PCV) is an ophthalmologic disease, characterized by vascular abnormalities of the walls of small choroidal vessels, reproducing the specific aspect of polyps (cluster aspect). PCV is one of the "boundary-forms" of age related macular degeneration.

These vasculopathies can be idiopathic. Following the radiotherapy treatments of active and occult-typed neovessels in Age-Related Macular Degeneration (ARMD), 10% of the patients would present typical polypoidal vasculopathic lesions. These polypoidal secondary lesions have been induced by radiotherapy treatment and may show an increased sensibility to radiation in these patients.

Such an increase of radiosensibility is noticed in ataxia telangiectasia syndrome, in relation to the ATM gene mutations. The secondary or idiopathic polypoidal vasculopathic lesions are to be brought closer to telangiectasias in Ataxia Telangiectasia. Considering the iatrogenic component of radiotherapy in the secondary forms of ataxia telangiectasia, it seems legitimate to search for predisposing variants to polypoidal vasculopathies in the ATM gene.

Considering the frequency of PCV worldwide, it seems important to identify the predisposing genetic factors of the ATM gene. These biomarkers to the pathology might enable us to offer prevention (reinforced protection against radiations, including light) and to develop therapeutics (recruitment of other kinases, ATM's partners, in the stability and cellular control of DNA).


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date October 23, 2018
Est. primary completion date October 23, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult caucasian patient

- Polypoidal choriodal vasculopathy

- Informed written consent

Exclusion Criteria:

- History of cephalic radiotherapy

- Absence of affiliation to social security or universal health coverage (CMU)

Study Design


Locations

Country Name City State
France Fondation Ophtalmologique A. de Rotchschild Paris

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variants in the ATM gene Compared analysis of the variants frequency (heterozygote, homozygote variants versus the wild variant) in the ATM gene. Day 1
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